High Intensity Functional Training in the Rehabilitation of Cancer Survivors

NCT04001127 | Completed

• 2 other identifiers: 514-0306/19-3000H-19010858
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate changes in health related quality of life (HRQoL) and cancer-related fatigue (CRF) following a 16-weeks of HIFT as a part of the rehabilitation of cancer survivors. Additionally, we will investigate the continuation of participation in any High Intensity Functional Training (HIFT) program, three as well as 12 months following completion of the exercise intervention. The intervention containing high intensity functional training will take place in a pragmatic clinical setting at the Center for Cancer and Health in Copenhagen. We hypothesize that the HIFT will be be associated with improved HRQoL and CRF.

Conditions

Cancer

Keywords

high intensity functional training; crossfit; cancer survivors

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  Change in HRQoL from baseline to end point and from end point to follow up at 3 and 12 months, will be evaluated using the Global Health Status/Quality of Life item from the EORTC QLQ-C-30 questionnaire. EORTC QLQ-C-30 includes five functional domains (physical, role, cognitive, emotional and social, where higher scores represent greater function or quality of life) and three symptom scales (fatigue, pain and nausea). Functional and symptom scales range from 0 to 100. Higher values on functional scales equal a higher level of functioning. Higher values on symptom scales equal higher symptom burden. EORTC QLQ-C-30 is chosen for it's established reliability and validity with specific emphasis on use in cancer populations

  For each participant at baseline + end point at 16 weeks + follow up at 3 month and 12 months)

Secondary Outcomes (3)

• Symptoms and function

  For each participant at baseline + end point at 16 weeks + follow up at 3 month and 12 months)

• Leisure time physical activity level

  Time frame for each participant: Baseline + end point at 16 weeks + follow up at 3 months and 12 months

• Continued participation in high intensity functional training (post-intervention)

  Time frame: for each participant at follow up at 3 month and 12 months

Study Arms (1)

High Intensity Functional Training

EXPERIMENTAL

Intervention group assigned to 16 weeks of group-based high intensity functional training supervised by physiotherapists.

Other: High Intensity Functional Training

Interventions

High Intensity Functional Training OTHER

The exercise intervention for this study will be HIFT, defined as a style of training that incorporates functional, multimodal movements, performed at relatively high intensity, and designed to improve parameters of general physical fitness and performance. The program design and template will be based on the principles of the HIFT program called CrossFit®. CrossFit is described as a strength and conditioning program that focuses on "constantly varying functional movements, performed at a relatively high intensity". CrossFit training includes a variety of elements from gymnastics (e.g., floor, bar and ring exercises), weightlifting exercises (e.g., squats, cleans, snatches and presses with a barbell, dumbbell or kettlebell), and cardiovascular activities (e.g., running or rowing).

High Intensity Functional Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients must be at least 18 years old
• Patients referred to the centre for cancer rehabilitation from any hospital or private practising general practitioner in the Capital Region in Denmark
• Patients who choose to participate in group based high intensity functional training that is offered at CCHC as part of their physical rehabilitation.
• Eligibility for participation in this study will be regardless of cancer treatment and the stage of the cancer. Thus, both patients undergoing active cancer treatment, patient who have completed active treatment as well as chronic cancer survivors will be considered eligible for participation in this study.
• Patients not able to reply to the questionnaire due to mental impairment
• Patients who are not able to read and understand Danish
• Patients who does not have an e-mail address because of the application of online-based questionnaires.

Sponsors & Collaborators

• Andreas Lund Hessner: lead

Study Sites (1)

Center for Cancer and Health Copenhagen

Copenhagen, København N, 2200, Denmark

Location

Related Publications (11)

• Cramp F, James A, Lambert J. The effects of resistance training on quality of life in cancer: a systematic literature review and meta-analysis. Support Care Cancer. 2010 Nov;18(11):1367-76. doi: 10.1007/s00520-010-0904-z. Epub 2010 May 26.

  PMID: 20502922 BACKGROUND

• Cheema B, Gaul CA, Lane K, Fiatarone Singh MA. Progressive resistance training in breast cancer: a systematic review of clinical trials. Breast Cancer Res Treat. 2008 May;109(1):9-26. doi: 10.1007/s10549-007-9638-0. Epub 2007 Jul 12.

  PMID: 17624588 BACKGROUND

• Spence RR, Heesch KC, Brown WJ. Exercise and cancer rehabilitation: a systematic review. Cancer Treat Rev. 2010 Apr;36(2):185-94. doi: 10.1016/j.ctrv.2009.11.003. Epub 2009 Dec 4.

  PMID: 19962830 BACKGROUND

• Fuller JT, Hartland MC, Maloney LT, Davison K. Therapeutic effects of aerobic and resistance exercises for cancer survivors: a systematic review of meta-analyses of clinical trials. Br J Sports Med. 2018 Oct;52(20):1311. doi: 10.1136/bjsports-2017-098285. Epub 2018 Mar 16.

  PMID: 29549149 BACKGROUND

• Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.

  PMID: 30087252 BACKGROUND

• Heinrich KM, Patel PM, O'Neal JL, Heinrich BS. High-intensity compared to moderate-intensity training for exercise initiation, enjoyment, adherence, and intentions: an intervention study. BMC Public Health. 2014 Aug 3;14:789. doi: 10.1186/1471-2458-14-789.

  PMID: 25086646 BACKGROUND

• Claudino JG, Gabbett TJ, Bourgeois F, Souza HS, Miranda RC, Mezencio B, Soncin R, Cardoso Filho CA, Bottaro M, Hernandez AJ, Amadio AC, Serrao JC. CrossFit Overview: Systematic Review and Meta-analysis. Sports Med Open. 2018 Feb 26;4(1):11. doi: 10.1186/s40798-018-0124-5.

  PMID: 29484512 BACKGROUND

• Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

  PMID: 4053261 BACKGROUND

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• Bechke E, Kliszczewicz B, Feito Y, Kelemen H, Nickerson B. Resting cardiac autonomic activity and body composition following a 16-week high-intensity functional training intervention in women: A pilot study. Journal of Human Sport & Exercise. 2017 Jul;12(3):680-8.

  BACKGROUND

• Heinrich KM, Becker C, Carlisle T, Gilmore K, Hauser J, Frye J, Harms CA. High-intensity functional training improves functional movement and body composition among cancer survivors: a pilot study. Eur J Cancer Care (Engl). 2015 Nov;24(6):812-7. doi: 10.1111/ecc.12338. Epub 2015 Jun 10.

  PMID: 26094701 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: This study is a single group clinical trial. A pragmatic design will be applied for this study as participants will be included consecutively as they are referred to the Center for Cancer and Health Copenhagen for cancer rehabilitation and agrees to participate in the study.

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 27, 2019
• Study Start: August 6, 2019
• Primary Completion: March 15, 2020
• Study Completion: April 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

DK (1)